Dr. Vaidehi Mehta

Strategic and detail-driven Safety Aggregate Report Specialist with proven expertise in Pharmacovigilance and Clinical Research, specializing in the preparation and submission of PBRER/PSUR, PADER, and Addendum to Clinical Overviews. Adept at interpreting and applying Global Regulatory Guidance (ICH, EMA, FDA) with a strong foundation in statistical and epidemiological methodologies to ensure compliance and scientific rigor. Passionate about advancing drug safety and efficacy, with a track record of delivering error-free aggregate safety reports under tight deadlines in fast-paced environments.

Recognized for meticulous attention to detail, cross-functional collaboration, and proactive problem-solving that consistently supports regulatory approvals and enhances patient outcomes.

Safety Writer - Fortrea

(2025-02)

• Authored and delivered global aggregate safety reports (PBRER, PSUR, PADER, Addendum Statements), achieving 100% on-time regulatory submissions and strengthening compliance across international markets.
• Directed planning meetings and client discussions to define search strategies, ensuring alignment with regulatory expectations and project objectives.
• Compilation of data for aggregate reports including line listing and summary tabulation.
• Discuss project details and obtain clarification on specific questions/issues/gaps with project POC.
• Ensuring the compliance of reports with regulatory guidance and SOPs.
• Coordinating with teams to resolve process-related issues.

Safety Aggregate Report Specialist - IQVIA - Bangalore

(2023-03 - 2025-01)

• Deeply knowledge about line listing generation for different reports
• Authored various aggregate periodic safety data reports including PSUR, PADER, PBRER, Addendum statement and other documents as assigned.
• Setting, discussing and meeting expectations of the document during kick off and subsequent meetings.
• Ability to effectively and proactively communicate to the multiple stakeholders.
• Ensure quality documents that objectively and accurately represent the data as per planned and documented guidelines and SOP.
• Quality review for various reports like APQRs, PADERs and ASs.

SENIOR DENTIST - I Smile Dental Clinic - Hyderabad

(2017-03 - 2018-03)

• Oral prophylaxis
• root canal therapy
• Extractions

PRIVAETLY OWNED CLINIC - Radhey Dental Clinic - Rajkot

(2013-06 - 2016-01)

• Crowns and Bridges
• Full mouth rehabilitation
• Crown cementation
• Extractions and minor surgical procedure
• Root canal Therapy

Certificate Course - Pharmacovigilance & Regulatory Affairs - Bangalore Clinical Research Institute (2023-01 - 2023-01)

Bachelor of Dental Surgery - Dental Surgery - PMNM Dental College (2012-04)